Cadence Pharmaceuticals Inc. ( CADX)

Q3 2010 Earnings Call

November 5, 2010 8:30 AM ET


Ted Schroeder – President and CEO

Jim Breitmeyer – Executive Vice President and CMF

Scott Byrd – Senior Vice President and CCO

Bill LaRue – Senior Vice President and CFO.


Charles Duncan – JMP Securities

Eric Schmidt – Cowen and Company

Adam Cutler – Canaccord Genuity

Joseph Schwartz – Leerink Swann

Irina Rivkind – Duncan Williams

Richard Lau – Wedbush Securities



Good morning. And welcome to the Cadence Pharmaceuticals Third Quarter 2010 Financial Results Conference Call. On the call today are Ted Schroeder, President and CEO; Jim Breitmeyer, Executive Vice President and Chief Medical Officer; Scott Byrd, Senior Vice President and Chief Commercial Officer; and Bill LaRue, Senior Vice President and Chief Financial Officer.

At this time, I would like to inform you that this conference is being recorded and that all participants are in a listen-only mode. At the request of the company we will open the conference for question-and-answer after the management presentation. (Operator Instructions)

Our first speaker is Bill LaRue. Please go ahead, sir.

Bill LaRue

Thank you. Good morning, everyone. Before we get started today, I’d like to remind you that statements included in this conference call that are not a description of historical facts are forward-looking statements. Such forward-looking statements include statements regarding our readiness for and anticipated timing for the planned commercial launch of OFIRMEV, OFIRMEV’s market potential and ability to fulfill unmet medical needs, our beliefs that pharmacoeconomic issues will not be a significant barrier to formulary approvals, the sufficiency of our company’s capital resources to fund our operations through the launch of OFIRMEV and our financial estimates or projections.

Our actual results may differ materially from those discussed during this conference call due to the risks and uncertainties inherent in our business which include, our dependence on the successful commercialization of OFIRMEV, the potential that will require substantial additional funding in order to effectively commercialize OFIRMEV, and the risk that we may not be able to raise sufficient capital when needed or at all, the risk that delays in commercially launching OFIRMEV would enable competitors to further entrench their existing products or develop and bring new products to market before OFIRMEV, our ability to ensure an adequate and continued supply of OFIRMEV, and our ability to comply with the terms of and draw down additional amounts under a loan agreement, and the potential for an event of default under a loan agreement, the impact of healthcare reform legislation and our ability to timely complete a required post-marketing efficacy study of OFIRMEV in infants and neonates.

These and other risks are detailed in our prior press releases and periodic public filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements and we undertake no obligation to revise or update such statements. All forward looking-statements are qualified by this cautionary statement.

This caution is made under the Safe Harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. If anyone has not seen our press release issued earlier today, you can access it on our website at Additionally, this conference call is being webcast through the company’s website and will be archived there for future reference. Ted?

Ted Schroeder

Thank you, Bill. Good morning, everyone, and thank you for joining us today. I’ll start by discussing the recent FDA approval of OFIRMEV and our ongoing preparations to launch the product. Next Bill will provide an overview of our third quarter and year-to-date financial results, and then we’ll open the call to your questions.

As you know, on November 2nd Cadence achieved a significant milestone with the approval by the FDA of OFIRMEV, a proprietary intravenous formulation of IV acetaminophen for the management of mild to moderate pain. The management of moderate to severe pain with adjunctive opioid analgesics and the reduction of fever, OFIRMEV is the first and only form of IV acetaminophen to be approved in the U.S.

In our pivotal clinical trials in patients undergoing hip or knee surgery, OFIRMEV resulted in significantly decreased pain intensity and reduced opioid consumption, as well as improved patient satisfaction when compared to placebo.

We firmly believe that OFIRMEV may benefit hospitalized patients by offering physicians a new non-opioid, non-NSAIDs treatment option for the management of pain and fever.

Our commercial leadership team led by Scott Byrd, our Chief Commercial Officer, and Randy St. Laurent, our VP of Sales, is excited about the positive feedback we’ve received about OFIRMEV from thought leaders across the country, as well as from our market research.

For example, surgeons and anesthesiologists surveyed in 2009 indicated that they would prescribe IV acetaminophen for more than 70% of patients experiencing post-operative pain.

As we have stated previously, we believe that OFIRMEV will achieve robust formulary adoption on the basis of its potential to fill unmet medical needs. In circumstances in which hospitals closely consider pharmacoeconomic benefits, we believe OFIRMEV’s value will be reinforced.

In particular, we’re encouraged by the potential to provide hospital formulary committees with published studies of IV acetaminophen that have demonstrated a reduction in opioid consumption, as well as decreased PACU time, post-surgical ambulation time and time to extubation in the ICU.

Our preparations for the launch of OFIRMEV early in the first quarter of 2010 are well underway. As we shared with you on Tuesday, immediately following the approval of OFIRMEV we initiated the process of hiring our sales team.

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